SDOH-Homecare Intervention Focus Team (SHIFT) Trial to Improve Stroke Outcomes

NCT06397937 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2026-04-08

No results posted yet for this study

Summary

Primary Goal:

To test the hypothesis that among stroke patients 18-75 years with ≥3 SDOH risk factors, SHIFT will improve: (1) functional outcomes as measured by the SIS (Primary Outcome), (2) physiological outcomes as measured by changes in blood pressure and cognition, (secondary outcomes) and (3) epigenetic allostatic load biomarkers (exploratory outcome) such as DNA methylation (DNAm) and telomere length, at 6 months and 1-year post-stroke, compared with usual care (UC).

Conditions

  • Stroke
  • Social Determinants of Health

Interventions

BEHAVIORAL

SHIFT team intervention

The SHIFT team, comprising a community health worker (CHW), community social worker (CHW), and community nurse (CN) will visit the participant starting within 72 hours of hospital discharge and provide social service referrals related to food insecurity, housing, immigration, and employment, and assist with medical appointment preparation (CHW), deliver individualized counseling focused on coping skills, reducing caregiver strain, and the psychological distress associated with experiences of racism and SDOH (CSW), and address health literacy and review of treatment goals and medications (CN).

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH
  • Columbia University

    lead OTHER

Principal Investigators

  • Olajide Williams, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-15
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06397937 on ClinicalTrials.gov